A third COVID-19 vaccine, developed by Novavax, will soon be available, joining Pfizer/BioNTech and Moderna in targeting current circulating variants. The U.S. Food and Drug Administration (FDA) has authorized the updated version of the Novavax vaccine for emergency use in people aged 12 and older.
This approval follows the FDA’s recent approval of updated versions of the Pfizer/BioNTech and Moderna vaccines. All three vaccines now include a monovalent component specifically targeting the Omicron variant JN.1 strain of the virus.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized the continued importance of COVID-19 vaccination as the most effective method of prevention. With the FDA’s authorization, Novavax provides an additional vaccine option that meets safety, effectiveness, and manufacturing quality standards.
This new vaccine can be administered in two doses, three weeks apart, for individuals who have not previously been vaccinated, while those partially vaccinated can receive a single dose.
Novavax’s New COVID-19 Vaccine Approved by FDA, Joining Pfizer/BioNTech and Moderna in Targeting Omicron Variant
The FDA has indicated that COVID-19 vaccines will require annual assessment, similar to seasonal influenza vaccines, with the last update occurring in September 2023. In response to the ongoing threat of COVID-19, the Department of Health and Human Services recently launched a national campaign titled “Risk Less. Do More” to raise public awareness about respiratory viruses and available vaccines.
The campaign aims to reduce severe illness and limit the spread of these viruses, particularly among high-risk populations.
Current data from the CDC shows that the KP.3.1.1 strain is the dominant variant in the United States, accounting for a significant percentage of clinical specimens. Although COVID-19 activity remains elevated nationwide, some areas are beginning to see early signs of decline.
The CDC no longer tracks individual cases but relies on sewage surveillance and limited hospital data to monitor the virus’s spread. The last official case update from the CDC in May 2023 reported over 103 million infections and more than 1.1 million deaths in the U.S.
Wastewater data from the CDC indicates that the virus is at “very high” levels nationally, marking the highest summer peak since July 2022. The majority of the U.S. is experiencing “high” or “very high” levels of the virus, with only Michigan reporting “low” levels.
Despite the availability of vaccines, only 22.5% of U.S. adults received the latest round of shots introduced last fall. The FDA initially issued Emergency Use Authorization for the Pfizer-BioNTech and Moderna vaccines in December 2020, with Novavax receiving approval in June 2022.
